510(k) K913521
K913521 is an FDA 510(k) premarket notification submitted by Zeon Medical Corp. for the device "XEMEX TEMPORARY PACING CATHETER A MODIFIED". The FDA issued a decision of Substantially Equivalent on December 27, 1991. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Zeon Medical Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 1991
- Date Received
- August 6, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type